The present invention relates to hydrogel surgical devices, and more particularly to hydrogel devices used for refractive surgery.
In recent years the use of surgical techniques for correction of ophthalmic refractive malfunction has progressed from experimental laboratory operations to widely accepted, commonplace procedures. Radial keratotomy (RK), photorefractive keratotomy (PRK), and myopic keratomileusis (MKM) have all become routine techniques in ophthalmology. Such aggressive surgical treatment is a relatively new development in ophthalmology. however, many patients require good uncorrected visual acuity for various occupations, such as pilots or professional athletes, and other patients seek good uncorrected visual acuity for cosmetic or psychological reasons. Moreover, some patients have subnormal vision, even when optimally corrected with spectacles or contact lenses, and seek surgical correction for improved vision.
Some photorefractive surgical techniques involve a lamellar keratotomy, in which a hinged flap of apical corneal tissue is created by incision in the cornea generally perpendicular to the primary visual axis. A second cut is then made, in which a thin wafer of stroma is removed. The flap is then returned to its initial position and permitted to heal in place. Removal of the thin wafer of stroma alters the conformation of the corneal apex, thereby modifying the refractive characteristics of the cornea. Clearly, the placement and formation of the second cut, as well as the thickness and planarity of the first incision, are crucial to the success of this technique.
Lamellar keratotomy has been performed using a microkeratome device, in which a high speed oscillating head supports a blade that creates the corneal cuts. However, the blade thickness, as well as the mechanical vibration and motion of the moving cutter limits the fineness and planarity of the incision, which in turn limits the potential for successful outcome of the surgery.
The use of surgical lasers has been approved by the U.S. FDA for carrying our lamellar keratotomy, in a procedure known by the acronym LASIK. A laser beam cuts tissue by forming a very narrow beam of light, and sweeping the beam through the corneal tissue. The energy density within the beam is sufficient to vaporize any cellular structure in its path, and the mechanism of the laser cutting process is essentially thermal pyrolysis. There is the opportunity for byproducts of tissue heating and burning to be formed in the process, and these byproducts can adversely affect the healing process of the surgical wound.
Recently, a high speed water jet has been used in lamellar keratotomy, in a technique termed hydrorefractive keratoplasty (HRK). A water jet having a diameter less than 50 .mu.m is used to form the corneal incisions. The water jet is far smaller in diameter than the thickness of a cutting blade, whereby the incisions may be much finer, resulting in less tissue trauma, better healing, and greater potential for success. Also, the water jet cuts, delaminates, and separates tissue by imparting very high kinetic energy; unlike laser cutting, there is no formation of byproducts of tissue oxidation and burning.
The water jet is a linear "beam" which must be swept through the corneal tissue to effect the necessary incisions. The mechanism to effect the beam movement consists generally of a track on which the water jet nozzle is mounted in slidable fashion. The prior art demonstrates a need for an improved mechanism for guiding a water jet cutting beam with greater resolution and control, and for controlling the thickness of the cut and the thickness and conformation of the stromal wafer.